Textile-based prothesis for laparoscopic surgery

ABSTRACT

The invention relates to a prosthesis ( 1 ) comprising a textile ( 2 ) of elongate shape defining a longitudinal axis A, and a resilient frame ( 3 ) connected to said textile along substantially the peripheral edge of the textile, said frame forming, in the area of each short side of the textile, at least one U-shaped bend ( 4 ) extending in the direction of the longitudinal axis, said frame being able to adopt an unstressed configuration, in which said textile is deployed, and a stressed configuration, in which said frame is subjected to a radial force directed towards said longitudinal axis and said textile forms at least one longitudinal fold.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a National Stage Application of PCT/EP14/061654under 35 USC § 371 (a), which claims priority of French PatentApplication Serial No. 13/55258 filed Jun. 7, 2013, the disclosures ofeach of the above-identified applications are hereby incorporated byreference in their entirety.

The present invention relates to a prosthesis based on a biocompatibletextile and more particularly intended to be implanted by laparoscopy,such as, for example, the wall reinforcement prostheses for repair ofhernias.

Wall reinforcement prostheses, for example for the abdominal wall, arewidely used in surgery. These prostheses are intended to treat herniasby temporarily or permanently filling a tissue defect. These prosthesesare generally made from a biocompatible prosthetic textile and can havea number of shapes, for example rectangular, circular or oval, dependingon the anatomical structure to which they are to adapt. Some of theseprostheses are made from entirely bioresorbable filaments and areintended to disappear after they have performed their reinforcingfunction during the period of cellular colonization and tissuerehabilitation. Others comprise non-bioresorbable filaments and areintended to remain permanently in the body of the patient.

Moreover, in order to minimize the trauma subsequent to any surgicalintervention, patients are increasingly operated on by laparoscopy whenthe type of intervention performed allows this. Laparoscopy requiresonly very small incisions through which a trocar is passed, with theprosthesis being conveyed inside the trocar to the implantation site.Open surgery is thus avoided, and the patient can soon leave hospital.Laparoscopy is particularly popular in surgical interventions performedin the abdomen, for example the treatment of hernias.

However, the trocars used in laparoscopic surgery generally have arelatively small calibrated diameter, which may vary, for example, from5 to 15 mm, in order to reduce as much as possible the size of theincision that is made. The prosthesis therefore has to be conveyedwithin a conduit of small diameter and must then be deployed at theimplantation site.

To carry out this step, the prosthesis is generally rolled up on itselfin order to make it slide in the conduit of the trocar or is introduceddirectly by force. For this step, the surgeon generally uses laparoscopyforceps to push/guide the prosthesis inside the trocar. These forcepstake up a lot of space in the trocar. The small diameter of the trocarmakes this step particularly difficult to carry out. If the rolling-upof the prosthesis is not correctly guided and effected, the textile mayform a plug in the trocar. The prosthesis no longer slides inside thetrocar, and it is very complicated to remove it from the latter.Moreover, even when the prosthesis has been correctly rolled up, theemergence of the prosthesis from the trocar and the deployment of theprosthesis at the implantation site are complex steps. Indeed, thesurgeon initially has to pull on the prosthesis in order to free it fromthe trocar, but without damaging it. He then has to deploy theprosthesis and spread the latter out perfectly. If the prosthesis doesnot spread out perfectly against the abdominal wall for example, theremay be a risk of a soft organ being inserted between the prosthesis andsaid wall, which can lead to risks of adherence, pain and intestinalocclusion and can increase the possibility of recurrence. It istherefore essential for the surgeon to ensure that no part of theprosthesis is folded and that no viscera or part of the intestine iscaught between the prosthesis and the abdominal wall. However, onaccount of the limited space at the implantation site, it may provecomplicated to deploy the prosthesis and then to orient it suitably withrespect to the surrounding anatomical structures.

There is therefore still the need for a prosthesis that is based on abiocompatible textile, that can be used for the repair of hernias, thatcan be easily introduced into a conduit such as that of a trocar ofsmall diameter, without damaging said textile, and that is able to bedeployed completely, and preferably easily, once the implantation sitein the body of the patient has been reached.

The present invention aims to meet such a need.

A first aspect of the invention concerns a prosthesis comprising:

-   -   at least one flexible biocompatible textile of generally        elongate shape defining a longitudinal axis, said textile being        delimited by a peripheral outer edge forming substantially two        opposite long sides and two opposite short sides, and    -   at least one reinforcing element for said textile,

characterized in that said reinforcing element is in the form of aresilient frame connected to said textile along substantially theperipheral edge of the textile, said frame forming, in the area of eachshort side of the textile, at least one U-shaped bend extending in thedirection of the longitudinal axis, said frame being able to adopt anunstressed configuration, in which said textile is deployed, and astressed configuration, in which said frame is subjected to a radialforce directed towards said longitudinal axis and said textile forms atleast one longitudinal fold.

The prosthesis according to the invention is able to be folded up alongat least one longitudinal fold in a very simple way, for example bypressing the frame together, in one hand, radially in the direction ofthe longitudinal axis of the prosthesis. Thus, the prosthesis is capableof adopting an elongate configuration, which is very compact in theradial direction, allowing it to pass easily through a trocar, withoutthe aid of additional tools. The frame is sufficiently resilient toallow the prosthesis to be folded in order to enter a trocar of smalldiameter, for example a diameter of 5 to 15 mm. When it emerges from thetrocar, the prosthesis is then capable of deploying automatically underthe action of the frame, which recovers its initial configuration in theabsence of the stresses from the walls of the trocar. The prosthesis iscapable of conforming to the anatomical structures and of remaining inplace once it has emerged from the trocar.

According to the present invention, “textile” is understood as anyarrangement or assembly of biocompatible yarns, fibres, filaments and/ormultifilaments, for example obtained by knitting, weaving, braiding, ornonwoven.

In the present application, “biocompatible” is understood as meaningthat the materials having this property can be implanted in the human oranimal body.

Within the meaning of the present application, a “flexible textile” isunderstood as a textile that can be folded up but that does not have aninherent elasticity allowing it to spontaneously recover a spread-outconfiguration once it has been folded up.

Within the meaning of the present application, a “resilient frame” isunderstood as a frame which, for example, can be semi-rigid and has aresiliency or elasticity allowing it to be deformed under the effect ofa temporary stress and allowing it to return to an initial state of restonce said stress has been removed. According to the present invention,the frame allows the textile, and therefore the prosthesis, to bepressed together in the radial direction towards the longitudinal axisof the textile.

This step of pressing together is made easier by the presence of theU-shaped bends, which are disposed on the short sides of the frame andgive the frame an additional elasticity. Thus, under the effect of theradial stress exerted on the long sides of the frame, the U-shaped bendsform a hard point acting as a guide element aligned on the longitudinalaxis of the prosthesis, making it easier to introduce the prosthesisinto a trocar in the direction of the longitudinal axis of theprosthesis and of the trocar.

The materials that may be suitable for producing the frame of theprosthesis according to the invention may be chosen from anybiocompatible material having a certain rigidity in order to meet therequirements described above.

In one embodiment, the frame is made of a bioresorbable material. In thepresent application, “bioresorbable” or “biodegradable” is understood tomean that the materials having this property are absorbed and/ordegraded by the tissues or washed from the implantation site anddisappear in vivo after a certain time, which may vary, for example,from a few hours to a few months, depending on the chemical nature ofthe materials.

Thus, the frame acts as a guide for the prosthesis for introducing thelatter into a trocar, then acts as a means of stiffening the prosthesisduring the positioning and implanting of the prosthesis, after which itgradually degrades when the textile has been recolonized by thesurrounding cells.

For example, the bioresorbable material can be chosen from amongpolylactic acid (PLA), polycaprolactones (PCL), polydioxanones (PDO),trimethylene carbonates (TMC), polyvinyl alcohol (PVA),polyhydroxyalkanoates (PHA), oxidized cellulose, polyglycolic acid(PGA), copolymers of these materials and mixtures thereof. For example,the bioresorbable material can be a copolymer of polylactic acid and ofpolyglycolic acid.

Alternatively, the frame of the prosthesis according to the invention ismade of a non-bioresorbable material chosen from among polypropylenes,polyesters such as polyethyleneterephthalates, polyamides, silicones,polyether ether ketone (PEEK), polyarylether ether ketone (PAEK),polyurethanes and mixtures thereof.

In another embodiment, said frame is formed by a combination ofbioresorbable material and of non-bioresorbable material.

The frame of the prosthesis according to the invention substantiallyfollows the peripheral edge of the textile, in other words it issubstantially parallel to this edge, and can, for example, be set backfrom the peripheral outer edge of the textile. Thus, by adopting theshape of the contour of the textile, the frame can have an outerperimeter lower than that of the peripheral outer edge of the textile.In other words, the peripheral outer edge of the textile can extendbeyond the frame by a certain distance. For example, this distance canbe greater than or equal to 1 mm. In other words, the frame and theperipheral outer edge of the textile are of similar geometrical shape,but the frame can have smaller dimensions than those of the peripheralouter edge of the textile.

In one embodiment, for each short side, said U-shaped bend extendstowards the outside of said frame. Thus, during the step of pressingtogether, each U-shaped bend forms a loop and therefore a hard pointfacilitating the introduction of the pressed-together prosthesis into atrocar of small diameter, for example a diameter of 5-15 mm. Then, whenthe prosthesis emerges from the trocar, the absence of stress exerted onthe long sides of the frame allows the latter to redeploy naturally andautomatically, and the textile recovers its initial spread-outconfiguration.

In one embodiment, for each short side, said U-shaped bend extendstowards the inside of said frame. For example, the frame can form asupplementary bend in the area of each long side, said supplementarybend extending towards the inside of the frame in a directionperpendicular to the longitudinal axis A. Such a shape of the framemakes it possible to easily press the prosthesis together and align iton the longitudinal axis A. Since the U-shaped bend of each short sideextends towards the inside of the frame, the step of pressing togethercauses the formation of two stubs at the ends of the pressed-togetherprosthesis, these two stubs making it easier to introduce the prosthesisinto the trocar.

In one embodiment, said frame is continuous. Thus, the step of pressingthe prosthesis together, by pressing the frame together towards thelongitudinal axis of the prosthesis, does not create any projectingelements that could potentially perforate and damage the tissues. Byvirtue of its nature and its shape, the frame only has rounded andatraumatic outer contours.

The frame of the prosthesis according to the invention is connected tosaid textile. For example, the frame can be fixed to the textile bysewing, ultrasonic welding, or else by adhesive bonding or moulding.

In one embodiment, the frame of the prosthesis according to theinvention is moulded over the textile. Thus, the frame is connected tothe textile by injection moulding of one or more thermoplastic orthermosetting biocompatible materials. For example, the mould of aninjection-moulding machine is equipped with an insert gate in which thetextile is held. One or more thermoplastic or thermosettingbiocompatible materials are then heated to their melting point andinjected into the mould, the latter having one or more channels of theshape desired for the frame. The holding of the textile, the precisionof the injection volume and the choice of the injection parameters makeit possible to obtain a frame without material loss, without flash andwith good surface evenness. Such a method allows the frame to be fixedto the textile in a particularly effective and lasting way.

In one embodiment, the frame is obtained by moulding a copolymer ofpolylactic acid and of polyglycolic acid over the textile.

The textile of the prosthesis according to the invention has a generallyelongate shape, for example rectangular, oval or elliptic. The textilecan have another initial shape and can then be cut to such an elongateshape, in particular to a shape adapted to the defect, for example thehernia defect, that is to be treated.

In one embodiment, said generally elongate shape is a rectangle. Inanother embodiment, said generally elongate shape is an ellipse. Such ashape is particularly advantageous, since it is similar to theanatomical shape of the defect that is to be filled. Moreover, whenpressed together, such a prosthesis adopts a shape that is perfectlyaligned on its longitudinal axis, permitting easier introduction into atrocar, even one of small diameter.

In one embodiment, the textile is a mesh.

Within the meaning of the present application, a “mesh” is understood asa textile, as defined above, which is openworked, that is to sayprovided with pores that favour recolonization of tissue. Such a meshcan be bioresorbable, permanent or partially bioresorbable. It issufficiently flexible to be folded up at the time of introduction intothe abdominal cavity. The mesh can be made from a layer of textile orseveral layers of textile. Such meshes are well known to a personskilled in the art.

In one embodiment of the invention, the mesh is a knit. By virtue of themeshwork of the knit, it is possible to obtain openworked faces thatpromote cell recolonization after implantation. The knit can betwo-dimensional or three-dimensional.

Within the meaning of the present application, a two-dimensional knit isunderstood as a knit having two opposite faces linked to each other bymeshes but devoid of a spacer giving it a certain thickness: such a knitcan be obtained, for example, by knitting yarns on a warp knittingmachine or raschel knitting machine using two guide bars. Examples ofknitting two-dimensional knits suitable for the present invention aregiven in the document WO2009/071998.

According to the present application, a three-dimensional knit isunderstood as a knit having two opposite faces linked to each other by aspacer that gives the knit a significant thickness, said spacer itselfbeing formed from additional linking yarns in addition to the yarnsforming the two faces of the knit. Such a knit can be obtained, forexample, on a double-bed warp knitting or raschel knitting machine usingseveral guide bars. Examples of knitting three-dimensional knitssuitable for the present invention are given in the documentsWO99/05990, WO2009/031035 and WO2009/071998.

In one embodiment of the invention, one face of the textile is coveredby a non-stick coating.

Such a non-stick coating makes it possible in particular to avoid theformation of undesired and serious post-surgical fibrous adhesions.

Within the meaning of the present application, “non-stick” is understoodas a smooth and non-porous biocompatible material or coating that doesnot offer space for cell recolonization and that preferably promotes thegrowth of peritoneum.

Another aspect of the present invention is a method by which aprosthesis of the kind described above is conveyed to an implantationsite, said method comprising the following steps:

-   -   the above prosthesis is pressed together in one hand, by folding        the two long sides of the textile over towards the medial        longitudinal axis of the prosthesis,    -   the longitudinal axis of the prosthesis, which has thereby been        made compact, is lined up with the longitudinal axis of a trocar        intended to receive said prosthesis,    -   said bend is introduced into the proximal orifice of the trocar,        and the compact prosthesis is pushed through the inside of the        trocar by a force directed along the longitudinal axis of the        trocar.

The prosthesis is thus pushed along the longitudinal axis of the trocaruntil its end emerges from the trocar via the distal orifice thereof.

The push is continued until the prosthesis has deployed completelyoutside the trocar. It may be possible to use forceps to pull on thedistal end of the prosthesis, or to use a pusher to continue pushing theprosthesis in the trocar.

In this application, the distal end of a device means the end farthestfrom the hand of the user, and the proximal end means the end nearest tothe hand of the user. Likewise in this application, the term “distaldirection” means the direction of introduction of the prosthesis intothe body of the patient, and the term “proximal direction” means thedirection opposite to this direction of introduction.

By virtue of the structure of the prosthesis according to the invention,the step of introducing the bend into the trocar is greatly facilitated.Likewise, with the prosthesis made perfectly compact, it passes throughthe trocar easily and without damage.

Finally, the automatic return of the frame to its initial configurationbrings about the automatic deployment of the prosthesis and the perfectspreading-out of the latter at the implantation site.

The advantages of the present invention will become clearer from thefollowing detailed description and from the attached drawings in which:

FIG. 1 shows a plan view of a first embodiment of a prosthesis accordingto the invention,

FIG. 2 shows a perspective view of one end of the prosthesis from FIG.1, when the prosthesis is in the compact shape,

FIG. 3 shows the step of introducing one end of the prosthesis from FIG.2 into the proximal orifice of a trocar,

FIG. 4 is a side view of the prosthesis from FIG. 1 in the compact shapeand partially introduced into the trocar from FIG. 3,

FIG. 5 is a side view of the prosthesis from FIG. 1 in the compact shapeand partially emerging from the trocar of FIG. 3,

FIG. 6 is a side view showing the automatic deployment of the prosthesisfrom FIG. 1 when it has emerged almost completely from the trocar ofFIG. 3,

FIG. 7 is a plan view of a second embodiment of the prosthesis accordingto the invention.

FIG. 1 shows an embodiment of a prosthesis 1 according to the invention.The prosthesis 1 comprises a biocompatible textile 2 and a reinforcingelement in the form of a frame 3.

As will be clear from FIG. 1, the textile 2 has a generally elongateshape defining a longitudinal axis A. The textile 2 is thus delimited bya peripheral outer edge 2 a forming substantially two opposite longsides 2 b, which are substantially parallel to the longitudinal axis A,and two opposite short sides 2 c, which are substantially perpendicularto the longitudinal axis A. In the example shown, the textile 2 has thegeneral shape of an ellipse. Such a shape is suitable for the repair ofa hernia of the abdominal wall, for example.

In other embodiments, the textile 2 could have an oval shape or arectangular shape or could be protean if the shape in question isgenerally elongate and defines a longitudinal axis.

The textile 2 is made up of an arrangement of biocompatible filaments,such as a knit, a woven or a nonwoven. Preferably, as is shown in FIG.1, the textile 2 is in the form of a mesh, that is to say it hasopenings for better tissue integration. For example, the textile 1 canbe a two-dimensional or three-dimensional knit. Such textiles in theform of meshes or knits are well known to a person skilled in the artand are not described in any greater detail here.

The textile 2 can be bioresorbable, permanent or partiallybioresorbable. As will become clear from the description below, thetextile 2 is sufficiently flexible to be folded up, in particular at thetime of introduction of the prosthesis into a trocar, along one or morelongitudinal folds. In general, however, the textile 2 does not have aninherent elasticity allowing it to spontaneously recover a spread-outconfiguration once it has been folded up. The textile 2 can be suppliedin the form of a band, which one cuts to the dimensions of the defect tobe treated.

Referring again to FIG. 1, and as will become clear on reading thedescription below, the frame 3 acts as an element reinforcing thetextile 2 in order to stiffen the latter and keep it in its generallyelongate shape, as a tool for guiding the prosthesis 1 at the time ofits introduction into a trocar, and as a tool for assisting in thedeployment of the prosthesis when the latter emerges from the trocar atthe implantation site. For this purpose, the frame 3 is connected to thetextile 2 and has an elasticity allowing it to be deformed under theeffect of a temporary stress and allowing it to return to an initialstate of rest once said stress has been removed.

The frame 3 is connected to the textile 2. It can be attached to thetextile 2 by means of a seam, or else by means of an ultrasonic weld, byadhesive bonding, or by injection moulding.

In one embodiment, the frame 3 is connected to the textile 2 byinjection moulding of one or more thermoplastic or thermosettingbiocompatible materials. Such an embodiment makes it possible to securethe fixing of the frame to the textile in a particularly effectivemanner and to produce the prostheses according to the invention at anindustrial scale.

In the injection moulding technique, a mould is formed in which, forexample, there is a cavity defining a contour which corresponds to thecontour of the frame that is to be obtained, namely a generallyelliptical contour as regards the example shown in FIGS. 1 and 2. Thetextile is held in an insert gate of the mould. The thermoplasticmaterial used to produce the frame, for example a copolymer ofpolylactic acid and of polyglycolic acid, is heated and injected intothe cavity using an injection moulding machine.

After the injection step, the mould is opened and the prosthesis 1 iswithdrawn from the mould. Such a method allows the textile to be“embedded” in the part moulded over it. Thus, the frame 3, which is theovermoulded part, is connected to the textile, without any risk of itscoming loose or fragmenting.

The frame 3 is continuous. Thus, as will become clear from thedescription below, the step of pressing the prosthesis together, bypressing the frame together towards the longitudinal axis of theprosthesis, does not create any projecting elements that couldpotentially perforate and damage the tissues. By virtue of its natureand its shape, the frame only has rounded and atraumatic outer contours.

In particular, the frame 3 has a structure, in other words a shape, anda nature, in other words a material, giving it an elasticity such thatit is able to adopt a first, unstressed configuration in which its shapefollows substantially the contour of the peripheral outer edge and inwhich the textile 2 and the prosthesis 1 are deployed and spread out asshown in FIG. 1, and a second, stressed configuration in which its twolong sides 3 b are brought towards the central longitudinal axis of thetextile 2, as shown in FIG. 2, and the prosthesis 1 has a compact shapein its radial direction.

Thus, in the example shown in FIG. 1, the frame 3, in its unstressedconfiguration, has substantially the shape of an ellipse, with twoopposite long sides 3 b, which are substantially parallel to thelongitudinal axis A, and two opposite short sides 3 c, which aresubstantially perpendicular to the longitudinal axis A. In the area ofeach of its short sides 3 c, the frame 3 forms a U-shaped bend 4extending, in the direction of the longitudinal axis A, towards theoutside of the frame 3. Thus, the frame 3 follows substantially theouter edge of the textile, being slightly set back from this edge.

Alternatively, in an embodiment not shown, in which the textile has arectangular shape with two opposite long sides and two opposite shortsides, the shape of the frame follows the contour of the outer edge ofthe textile and likewise describes a rectangle with two opposite longsides and two opposite short sides, each of its opposite short sidesbeing provided with a bend extending towards the outside of the frame oralternatively towards the inside of the frame.

On account of the nature and the structure of the frame 3, the U-shapedbends 4 act as guides for introducing the prosthesis 1 into a smallorifice, such as an admission orifice of a trocar, when the frame 3 isin its stressed configuration. Indeed, when the user, for example usinghis hand, exerts a radial pressure on the opposite long sides of theframe 3 towards the longitudinal axis of the prosthesis 1, the resultingdeformation of the frame 3 projects the U-shaped bends 4 towards theoutside of the frame, as is shown in FIG. 3, the two opposite bends 4remaining aligned on the longitudinal axis A.

Thus, in order to easily introduce the prosthesis 1 from FIG. 1 into atrocar, the user uses his hand 10 to exert the above-described radialpressure on the long sides 3 b of the frame 3, as has been describedwith reference to FIG. 2, placing to the front, at each end of theprosthesis, the corresponding U-shaped bend 4. The prosthesis 1 then hasa compact configuration in its radial part, substantially aligned on thelongitudinal axis A of the textile 2 which forms at least onelongitudinal fold. Depending on how the prosthesis 1 is folded and/or onthe degree of stress applied to the frame 3, the textile 2 can formseveral longitudinal folds, like an accordion.

The user then takes hold of a trocar 5 into which he wishes to introducethe prosthesis 1. He brings the U-shaped bend 4, situated in the distalposition and forming a guide element, towards the proximal orifice 5 aof the trocar 5 and introduces it into the trocar 5. By virtue of itsstructure and its nature, the U-shaped bend 4 is sufficiently rigid toeasily enter the conduit of the trocar 5 and to continue advancing underthe effect of a distal push exerted by the user, as is shown in FIG. 3.

By virtue of its elongate compact shape, and the rigidity conferred onit by the presence of the frame 3, the prosthesis 1 also easily entersthe conduit of the trocar 5, until the first U-shaped bend 4 of theframe 3 appears through the distal orifice 5 b of the trocar, bringingwith it the textile 2 to which it is connected, as is shown in FIG. 4.

The user continues to exert a distal push on the prosthesis 1, inparticular on the frame 3 and on the proximally situated U-shaped bend 4thereof which stiffens the prosthesis 1. As is shown in FIG. 5, as alarger part of the textile 2 of the prosthesis 1 gradually escapes fromthe stresses of the walls of the trocar 5, the frame 3 returns little bylittle to its initial state of rest and causes the automatic deploymentof the textile 2 and, therefore, of the prosthesis 1. When theprosthesis 1 has emerged almost completely from the trocar 5, as isshown in FIG. 6, the frame 3 has practically recovered its ellipse shapecorresponding to its unstressed configuration, and the textile 2 andtherefore the prosthesis 1 are perfectly deployed and spread out.

The prosthesis 1 is then ready to be positioned opposite a hernia defectto be treated, without any risk of folds forming in the textile 2. Therisks of adherence or insertion of surrounding organs in such folds arethus very much limited.

FIG. 7 shows another embodiment of the prosthesis 1 according to theinvention, in which the textile 2 and the frame 3 also generally havethe shape of an ellipse. However, in the example shown in this figure,the frame 3 forms a bend 6 which, in the direction of the longitudinalaxis A, extends towards the inside of the frame 3, in the area of eachof the short sides 3 c thereof. Moreover, in the area of each of itslong sides 3 b, the frame 3 forms a supplementary bend 8, which extendstowards the inside of the frame 3 in a direction perpendicular to thelongitudinal axis A.

The presence of the bends 6 and of the supplementary bends 8 gives theframe 3 increased elasticity in the direction perpendicular to thelongitudinal axis A. Such a shape of the frame 3 makes it possible toeasily press the prosthesis 1 together and align it on the longitudinalaxis A in the stressed configuration of the frame 3. Since the bends 6on the short sides 3 c extend towards the inside of the frame 3, thestep of pressing together causes the formation of two stubs 7 on theframe 3 at each end of the prosthesis 1, these two stubs 7 acting asguide elements for the prosthesis 1 and making it easier to introducethe latter into the trocar, as has been explained above for theembodiment in FIG. 1.

The prosthesis according to the invention can thus be easily introducedinto a trocar, without requiring the help of an additional tool, andwithout any risk of forming a plug inside the trocar. By virtue of itsnature and its structure, the frame of the prosthesis according to theinvention acts as a reinforcing element for the textile and stiffens theprosthesis, as an element for guiding and transporting the prosthesisinside a trocar conduit of particularly small diameter, such as adiameter of 5-15 mm, and also as a tool for assisting in the automaticand perfect spreading-out of the prosthesis at the moment when thelatter emerges from the trocar at the implantation site.

The invention claimed is:
 1. A prosthesis comprising: at least oneflexible biocompatible textile of generally elongate shape defining alongitudinal axis, the textile being delimited by a peripheral outeredge forming substantially two opposite long sides and first and secondopposite short sides, and at least one reinforcing element for thetextile, wherein the reinforcing element is in the form of a resilientframe connected to the textile along substantially the peripheral outeredge of the long sides of the textile, the frame being set back from theperipheral outer edge and including a proximal U-shaped bend beingconvex to the peripheral outer edge of the first short side of thetextile and a distal U-shaped bend being convex to the peripheral outeredge of the second short side of the textile, the proximal and distalU-shaped bends extending along a central longitudinal axis of thetextile, the frame being able to adopt an unstressed configuration, inwhich the textile is deployed, and a stressed configuration, in whichthe frame is subjected to a radial force directed towards thelongitudinal axis, the textile forms at least one longitudinal fold, andeach of the proximal and distal U-shaped bends form a loop along thecentral longitudinal axis, the loop of the distal U-shaped bend forminga hard point configured to facilitate introduction of the prosthesisinto a trocar and the loop of the proximal U-shaped bend forming a hardpoint configured to facilitate advancement of the prosthesis through adistal orifice of the trocar.
 2. The prosthesis according to claim 1,wherein the frame is continuous.
 3. The prosthesis according to claim 1,wherein the reinforcing element is molded over the textile.
 4. Theprosthesis according to claim 1, wherein the reinforcing elementcomprises a bioresorbable material.
 5. The prosthesis according to claim4, wherein the bioresorbable material is selected from the groupconsisting of polylactic acid, polycaprolactone, polydioxanones,trimethylene carbonates, polyvinyl alcohols, polyhydroxyalkanoates,oxidized cellulose, polyglycolic acid, and mixtures thereof.
 6. Theprosthesis according to claim 1, wherein the reinforcing elementcomprises a non-bioresorbable material.
 7. The prosthesis according toclaim 6, wherein the non-bioresorbable material is selected from thegroup consisting of polypropylenes, polyethylene terephthalates,polyamides, silicones, polyether ether ketones, polyarylether etherketone, polyurethanes, and mixtures thereof.
 8. The prosthesis accordingto claim 1, wherein the reinforcing element comprises a copolymer ofpolylactic acid and polyglycolic acid.
 9. The prosthesis according toclaim 1, wherein the reinforcing element comprises rounded andatraumatic outer contours.
 10. The prosthesis according to claim 1,wherein the generally elongate shape is a rectangle.
 11. The prosthesisaccording to claim 1, wherein the generally elongate shape is anellipse.
 12. The prosthesis according to claim 1, wherein thebiocompatible textile is a two-dimensional knit mesh.
 13. The prosthesisaccording to claim 1, wherein the biocompatible textile is athree-dimensional knit mesh.
 14. The prosthesis according to claim 1,wherein one face of the biocompatible textile comprises a non-stickcoating.
 15. The prosthesis according to claim 1, wherein the frame issubstantially parallel to the peripheral outer edge along the longsides.
 16. The prosthesis according to claim 1, wherein the U-shapedbend is concave to a center of the textile.
 17. A method of conveying aprosthesis to an implantation site comprising: providing a prosthesisincluding at least one flexible biocompatible textile of generallyelongate shape defining a medial longitudinal axis, the textile beingdelimited by a peripheral outer edge forming substantially two oppositelong sides and first and second opposite short sides, and at least onereinforcing element for the textile, wherein the reinforcing element isin the form of a resilient frame connected to the textile alongsubstantially the peripheral outer edge of the long sides of thetextile, the frame being set back from the peripheral outer edge andincluding a proximal U-shaped bend being convex to the peripheral outeredge of the first short side of the textile, and a distal U-shaped bendbeing convex to the peripheral outer edge of the second short side ofthe textile, the proximal and distal U-shaped bends extending along themedial longitudinal axis of the textile, folding the two opposite longsides of the textile over the medial longitudinal axis via the proximaland distal U-shaped bends to place the textile in a stressedconfiguration, each of the proximal and distal U-shaped bends forming aloop along the medial longitudinal axis, the loop of the distal U-shapedbend forming a hard point configured to facilitate introduction of theprosthesis into a trocar and the loop of the proximal U-shaped bendforming a hard point configured to facilitate advancement of theprosthesis through a distal orifice of the trocar, introducing thetextile in the stressed configuration into a proximal orifice of atrocar via the hard point formed by the loop of the distal U-shapedbend, and advancing the textile via the hard point of the proximalU-shaped bend through a distal orifice of the trocar to the site ofimplantation wherein the textile automatically unfolds from the stressedconfiguration to an unstressed configuration.
 18. A prosthesiscomprising: a flexible biocompatible textile of an elliptical shapedefining a central longitudinal axis, the textile being delimited by aperipheral outer edge, and a reinforcing element in the form of aresilient frame connected to the textile, the frame including a firstlong side having a proximal and distal end, a second long side having aproximal and distal end, the first and second long sides positioned onopposite sides of the central longitudinal axis and defining a generallyelliptical shape, a first U-shaped bend connected to the proximal endsof the first and second long sides of the frame and extending along thecentral longitudinal axis away from the proximal ends of the first andsecond long sides of the frame, and a second U-shaped bend connected tothe distal ends of the first and second long sides of the frame andextending along the central longitudinal axis away from the distal endsof the first and second long sides of the frame, the first and secondU-shaped bends each being convex to the peripheral outer edge of thetextile.
 19. The prosthesis of claim 18, wherein the first and secondU-shaped bends are closer to the peripheral outer edge of the textilethan the proximal and distal ends of the first and second long sides ofthe frame.
 20. The prosthesis of claim 19, wherein the frame is able toadopt an unstressed configuration, in which the textile is deployed, anda stressed configuration, in which the frame is subjected to a radialforce directed towards the central longitudinal axis and each of thefirst and second U-shaped bends form a hard point acting as a guideelement along the central longitudinal axis to facilitate introductionof the prosthesis into a trocar and advancement of the prosthesisthrough the trocar to a site of implantation.